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Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment

3. Juni 2026 aktualisiert von: SWOG Cancer Research Network

A Phase II Randomized Study of Blinatumomab With or Without Revumenib for Patients With KMT2A-Translocation B-Cell Acute Lymphoblastic Leukemia (ALL)/ Acute Leukemia With Ambiguous Lineage (ALAL) With Persistent Measurable Residual Disease (MRD)

This phase II trial tests how well adding revumenib to usual treatment (blinatumomab) compared to usual treatment alone works in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation. Revumenib binds to a protein called menin and keeps it from binding to another protein called KMT2A. This stops or slows the growth of leukemia cells with changes in the KMT2A gene. Blinatumomab binds to CD19, which is found on most B cells (a type of white blood cell) and some types of leukemia cells. It also binds to a protein called CD3, which is found on T cells (another type of white blood cell). This may help the immune system kill cancer cells. In addition to blinatumomab, usual treatment also includes dexamethasone, methotrexate, cyclophosphamide, cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, daunorubicin, vincristine and leucovorin. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Chemotherapy drugs, such as cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Leucovorin is also being studied in the treatment of cancer. It is a type of chemoprotective agent and a type of chemosensitizing agent. Adding revumenib to usual treatment with blinatumomab may be safe, tolerable and more effective than blinatumomab alone in lowering the amount of leukemia in patients with B-ALL or ALAL with the KMT2A translocation.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

PRIMARY OBJECTIVES:

I. Among participants enrolled to the safety run-in cohort, to evaluate the safety of blinatumomab with revumenib in this participant population. (Cohort A: Children [≥ 1 year] and adults with CD19-positive [CD19+] KMT2Ar B-cell acute lymphoblastic leukemia [ALL]/ acute leukemia with ambiguous lineage [ALAL] in morphological first complete remission [CR1]) II. First primary randomized objective: Among participants with positive measurable residual disease (MRD) by clonoSEQ before randomization, to compare the rates of MRD negative complete remission (CR) by clonoSEQ after the completion of one cycle of blinatumomab versus one cycle of blinatumomab plus revumenib. (Cohort A: Children [≥ 1 year] and adults with CD19-positive [CD19+] KMT2Ar B-cell acute lymphoblastic leukemia [ALL]/ acute leukemia with ambiguous lineage [ALAL] in morphological first complete remission [CR1]) III. Secondary primary randomized objective (hierarchical tested): Among participants with positive MRD by clonoSEQ before randomization, if rates of MRD negative CR by clonoSEQ after completion of one cycle of therapy are improved with blinatumomab plus revumenib versus blinatumomab, to evaluate whether MRD-event-free survival is improved among patients randomized to blinatumomab plus revumenib versus blinatumomab. (Cohort A: Children [≥ 1 year] and adults with CD19-positive [CD19+] KMT2Ar B-cell acute lymphoblastic leukemia [ALL]/ acute leukemia with ambiguous lineage [ALAL] in morphological first complete remission [CR1]) IV. To describe and evaluate the feasibility of revumenib in combination with reduced intensity multiagent chemotherapy in this participant population. (Cohort B: Untreated newly diagnosed KMT2Ar B/T-ALL or ALAL in older adults [age ≥ 55 years])

SECONDARY OBJECTIVES:

I. Within each arm and cohort and across cycles of therapy, to estimate the frequency and severity of toxicities.

II. In Cohort A: Among participants with positive MRD by clonoSEQ before randomization, to estimate the rate of MRD negative CR by clonoSEQ after two cycles of blinatumomab or blinatumomab plus revumenib.

III. In Cohort A: Among participants with negative MRD by clonoSEQ before randomization, to estimate 6-month event-free survival and MRD-event-free survival in each arm.

IV. In Cohort A: Among participants with negative MRD by clonoSEQ before randomization, to estimate 6-month event-free survival in each arm.

V. In Cohort B: To estimate the post induction composite morphological CR (CR/CR with incomplete count recovery [CRi]) rate.

VI. To estimate proportion of participants MRD negative by multi-color flow cytometry after induction (Cohort B) and cycle 1 of blinatumomab (Cohorts A + B, including the safety cohort of Cohort A).

VII. Within each arm and cohort cohort (including the safety cohort of Cohort A): To estimate the rates of lineage switch and/or CD19-negative (CD19-) relapse.

VIII. Within each arm and cohort cohort (including the safety cohort of Cohort A): To estimate the rate of allogeneic hematopoietic stem cell transplantation (HSCT) in CR1.

IX. Within each arm and cohort cohort (including the safety cohort of Cohort A): To estimate event-free survival (EFS), MRD-EFS, relapse-free survival (RFS), progression-free survival (PFS), and MRD-PFS within each arm and cohort (including the safety cohort of Cohort A) and by age ≥ 1 year to < 18 years versus ≥ 18 years of age.

X. Within each arm and cohort cohort (including the safety cohort of Cohort A): To estimate time to MRD relapse by flow cytometry and/or clonoSEQ.

XI. Within each arm and cohort cohort (including the safety cohort of Cohort A): To estimate overall survival (OS).

TRANSLATIONAL MEDICINE OBJECTIVES:

I. To estimate the frequency of MEN1 mutations by quantitative polymerase chain reaction (qPCR) and/or high sensitivity next generation sequencing (NGS) pre-induction (Cohort B), pre-randomization (Cohort A), after blinatumomab treatment (Cohorts A and B) and at the time of relapse (Cohorts A and B). (Primary) II. To estimate the rate of KMT2A fusion reverse transcriptase (RT)-PCR MRD negativity after the first and second cycle of blinatumomab therapy within treatment arms in Cohort A. (Secondary) III. To estimate the rate of KMT2A fusion RT-PCR MRD negativity after chemotherapy induction and blinatumomab post-induction therapy in Cohort B. (Secondary) V. To estimate the rate of immunoglobulin (IG)/T cell receptor (TR) variable (V) (diversity [D]) joining (J) next generation (NGS) MRD negative remission after first and second cycle of blinatumomab across treatment cohorts in Cohort A (among those with diagnosis specimens available) and after induction and blinatumomab (if administered) in Cohort B. (Secondary) V. To descriptively report changes in gene expression between diagnosis (in Cohort B, and as available in Cohort A) and relapse samples by ribonucleic acid (RNA) sequencing of registration and relapse samples. (Secondary)

OUTLINE: Patients 1 year of age or older with B-cell ALL or ALAL are assigned to Cohort A. Patients 55 and older with B-ALL, T-ALL or ALAL are assigned to Cohort B.

COHORT A: The first 6-12 eligible patients are assigned to Arm 1. Subsequent patients are randomized to Arm 1 or Arm 2.

ARM 1:

BLINATUMOMAB AND REVUMENIB CYCLE 1 (35 DAYS): Patients receive revumenib orally (PO) twice daily (BID) on days 4-28 of cycle 1, blinatumomab intravenously (IV) continuously on days 1-28 of cycle 1, dexamethasone PO or IV on days 1 and 8 (if indicated) of cycle 1, and methotrexate intrathecally (IT) on days 1 and 15 of cycle 1.

CONSOLIDATION PART 1 AND PART 2 (56 DAYS): Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO once daily (QD) on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22 or on days 1, 8, 29, and 43, vincristine IV on days 15, 22, 43, and 50 and calaspargase pegol IV over 1-2 hours on days 15 and 43 in the absence of disease progression or unacceptable toxicity.

BLINATUMOMAB AND REVUMENIB CYCLE 2 (35 DAYS): Patients receive revumenib PO BID on days 1-28 of cycle 2, blinatumomab IV continuously on days 1-28 of cycle 2, dexamethasone PO or IV on day 1 of cycle 2, and methotrexate IT on days 1 and 15 of cycle 2.

INTERIM MAINTENANCE 1 (63 DAYS): Patients receive vincristine IV on days 1, 15, 29, and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO on days 1-14, 15-28, 29-42, and 43-56, and methotrexate IT on days 1 and 29 in the absence of disease progression or unacceptable toxicity.

DELAYED INTENSIFICATION PART 1 AND PART 2 (63 DAYS): Patients receive methotrexate IT on days 1, 29, and 36, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine IV on days 1, 8, 15, 43, and 50, doxorubicin IV over 3-15 minutes on days 1, 8, and 15, calaspargase pegol IV over 1-2 hours on days 4 and 43, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42 and cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39 in the absence of disease progression or unacceptable toxicity.

INTERIM MAINTENANCE 2 (56 DAYS): Patients receive vincristine IV on days 1, 11, 21, 31, and 41, methotrexate IV on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31 and calaspargase pegol IV over 1-2 hours on days 2 and 23 in the absence of disease progression or unacceptable toxicity.

Additionally, patients undergo chest x-ray and echocardiography (ECHO) or multigated acquisition scan (MUGA) at screening and bone marrow biopsy and aspiration, cerebrospinal fluid (CSF) and blood sample collection, computed tomography (CT) or positron emission tomography (PET)/CT throughout the study.

ARM 2:

BLINATUMOMAB CYCLE 1 (35 DAYS): Patients blinatumomab IV continuously on days 1-28 of cycle 1, dexamethasone PO or IV on days 1 and 8 (if indicated) of cycle 1, and methotrexate IT on days 1 and 15 of cycle 1.

CONSOLIDATION PART 1 AND PART 2 (56 DAYS): Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO QD on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22 or on days 1, 8, 29, and 43, vincristine IV on days 15, 22, 43, and 50 and calaspargase pegol IV over 1-2 hours on days 15 and 43 in the absence of disease progression or unacceptable toxicity.

BLINATUMOMAB CYCLE 2 (35 DAYS): Patients receive blinatumomab IV continuously on days 1-28 of cycle 2, dexamethasone PO or IV on day 1 of cycle 2, and methotrexate IT on days 1 and 15 of cycle 2.

INTERIM MAINTENANCE 1 (63 DAYS): Patients receive vincristine IV on days 1, 15, 29, and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO on days 1-14, 15-28, 29-42, and 43-56, and methotrexate IT on days 1 and 29 in the absence of disease progression or unacceptable toxicity.

DELAYED INTENSIFICATION PART 1 AND PART 2 (63 DAYS): Patients receive methotrexate IT on days 1, 29, and 36, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine IV on days 1, 8, 15, 43, and 50, doxorubicin IV over 3-15 minutes on days 1, 8, and 15, calaspargase pegol IV over 1-2 hours on days 4 and 43, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39 in the absence of disease progression or unacceptable toxicity.

INTERIM MAINTENANCE 2 (56 DAYS): Patients receive vincristine IV on days 1, 11, 21, 31, and 41, methotrexate IV on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31 and calaspargase pegol IV over 1-2 hours on days 2 and 23 in the absence of disease progression or unacceptable toxicity.

Additionally, patients undergo chest x-ray and ECHO or MUGA at screening and bone marrow biopsy and aspiration, CSF and blood sample collection, CT or PET/CT throughout the study.

COHORT B:

INDUCTION (35 DAYS): Patients receive cytarabine IT on day 1 of cycle 1, vincristine IV on days 1, 8, 15, and 22 of cycle 1, dexamethasone PO or IV BID on days 1-7 and 15-21 or IV BID on days 1-7 of cycle 1, daunorubicin IV on days 1, 8, and 15 of cycle 1, methotrexate IT on days 8 and 29 or once weekly of cycle 1, and revumenib PO BID on days 8-28 of cycle 1.

POST-INDUCTION (84 DAYS): Patients with morphological CR after induction treatment may receive revumenib PO BID on days 4-28 of cycle 1 and on days 1-28 of cycle 2, blinatumomab IV continuously on days 1-28 of cycles 1 and 2 and methotrexate IT on days 1 and 15 of cycles 1 and 2. Cycles repeat every 42 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

Additionally, patients undergo bone marrow biopsy and aspiration, CSF and blood sample collection, CT or PET/CT throughout the study.

After completion of study treatment, patients are followed every 3 months for the first 2 years, every 6 months for years 3-5 and then annually for up to 10 years after registration.

Studientyp

Interventionell

Einschreibung (Geschätzt)

90

Phase

  • Phase 2

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • COHORT A: Participants must meet diagnostic criteria for either B-cell acute lymphoblastic leukemia (ALL) with KMT2A-translocation or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation
  • COHORT A: Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)
  • COHORT A: Participants must have achieved morphological first complete remission (CR1) after induction cycle (s) as defined bone marrow lymphoblasts < 5%

  • COHORT A: Participants must have either known trackable clone(s) by clonoSEQ that was identified at initial diagnosis, or a banked diagnostic sample, which can include clinical samples from the treating institution, available that can be used to identify trackable clone(s)

    • Participants must not be known not to have trackable clones by clonoSEQ
    • Participants must not be known already to have MRD-negativity by clonoSEQ prior to enrollment
  • COHORT A: Participants must have evidence of CD19 expression at any level in ALL or ALAL documented locally by flow cytometry or immunohistochemistry in bone marrow or peripheral blood at the time of initial diagnosis. Immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage. Appropriate marker studies including CD19 (B cell) must be performed. If a bone marrow aspirate cannot be obtained despite an attempt (dry tap), appropriate Immunohistochemistry (IHC) testing, including CD19, must be performed on the bone marrow biopsy to determine lineage
  • COHORT A: Participants must have Philadelphia-chromosome negative ALL or ALAL
  • COHORT A: Participants must not have known lymphoid blast crisis arising from chronic myeloid leukemia (CML) or have received previous tyrosine kinase inhibitor (TKI) therapy for their chronic myeloid leukemia (CML)

  • COHORT B: Participants must meet diagnostic criteria for either newly diagnosed with acute lymphoblastic leukemia (ALL) or acute leukemia with ambiguous lineage (ALAL)

    • Participants with either B or T-cell subtypes of ALL are permitted on Cohort B
    • Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)
  • COHORT B: Participants must have Philadelphia-chromosome negative ALL or ALAL
  • COHORT B: Participants must not have known lymphoid blast crisis arising from CML or have received previous TKI therapy for their chronic myeloid leukemia (CML)
  • COHORT A: Participants ≥ 18 years may have received 1 to 3 cycles of induction/consolidation before entering the study. It is encouraged to enroll participants immediately after completing the first induction cycle if the patient achieves morphological CR. For pediatric patients < 18 years of age, enrollment must occur after induction therapy
  • COHORT A: Participants must discontinue strong cytochrome P450 (CYP)3A4 inhibitors or strong or moderate inducers, except corticosteroids, within 14 days prior to registration

  • COHORT A: Participants must have recovered from any prior major surgery adverse effects at least 14 days prior to registration, to the satisfaction of the local investigator

    • Note: Central venous access placement is not considered major surgery for the purposes of this protocol
  • COHORT A: Participants must not be receiving any oral or intravenous systemic immunosuppressive therapy with the exception of induction/consolidation chemotherapy for the treatment of their current ALL or ALAL. Participants may receive up to 10 mg per day of prednisone or prednisone equivalent for adrenal insufficiency or other indications
  • COHORT A: Participants must not have received a prior allogeneic hematopoietic stem cell transplant
  • COHORT A: Participants must not have received prior blinatumomab, menin inhibitors, chimeric antigen receptor (CAR)-T therapy, or anti-CD19 antibodies

  • COHORT B: Participants must not have received prior systemic therapy for ALL or ALAL, with the exception of hydroxyurea, steroid, retinoic acid, intrathecal chemotherapy, or induction chemotherapy as defined below

    • Participants who have been started on the study regimen backbone (i.e. induction therapy) before consenting and then are found to have the KMT2Ar and are eligible for the study, can be enrolled on the study as long as revumenib treatment can be started by day 8 of induction therapy
  • COHORT B: Participants must discontinue strong CYP3A4 inhibitors or strong or moderate inducers, except corticosteroids, within 14 days prior to registration

  • COHORT B: Participants must have recovered from any prior major surgery adverse effects at least 14 days prior to registration, to the satisfaction of the local investigator

    • Note: Central venous access placement is not considered major surgery for the purposes of this protocol
  • COHORT B: Participants must not be receiving any systemic oral or intravenous immunosuppressive therapy with the exception of induction chemotherapy or corticosteroid for the treatment of their current ALL or ALAL
  • COHORT B: Participants must not have received a prior allogeneic hematopoietic stem cell transplant
  • COHORT A: Participant must be ≥ 1 years old at the time of registration. There is no upper age limit
  • COHORT A: Participant must have Zubrod/Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, or Lansky/Karnofsky performance status scores of 50-100
  • COHORT A: Participants must have a complete medical history and physical exam within 28 days prior to registration
  • COHORT A: Glomerular filtration rate (GFR) ≥ 50 ml/min/1.73 m^2 (within 14 days prior to registration)
  • COHORT A: Absolute neutrophil count ≥ 1 x 10^3/uL (within 14 days prior to registration)
  • COHORT A: Platelets ≥ 100 x 10^3/uL (within 14 days prior to registration)

  • COHORT A: Direct bilirubin ≤ 2.0 mg/dL (34.2 micromoles/L) (within 14 days prior to registration)

    • Note: Participants with history of Gilbert's disease must have direct bilirubin ≤ 5 x institutional upper limit of normal (ULN)
  • COHORT A: Alanine aminotransferase (ALT) ≤ 5 x institutional ULN (within 14 days prior to registration)
  • COHORT A: Participants ≥ 18 years must have a calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 14 days prior to registration

  • COHORT A: Adequate renal function for participants < 18 years of age is defined as:

    • A GFR ≥ 50 mL/min/1.73 m^2, as determined by one of the following methods:

      • Estimated GFR (eGFR) ≥ 50 mL/min/1.73 m^2 "Bedside" Schwartz formula (2009)
      • Measured GFR ≥ 50 mL/min/1.73 m^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard)
  • COHORT A: Participants must have adequate cardiac function. Participants must have cardiac ejection fraction ≥ 50% by MUGA or 2 dimensional (2-D) echocardiogram or shortening fraction (SF) ≥ 27% by echocardiogram within 90 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
  • COHORT A: Participants ≥ 18 years of age with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
  • COHORT A: Participants ≥ 18 years of age with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated
  • COHORT A: Participants ≥ 18 years of age with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated
  • COHORT A: Participants must not have prolonged Fridericia's formula-corrected QT interval (QTcf) defined as > 450 msec on screening electrocardiogram (EKG) prior to registration
  • COHORT A: Participants must not have relapsed or refractory disease in the bone marrow (≥ 5% blasts) or extramedullary sites involvement
  • COHORT A: Participants must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) as determined by the local investigator
  • COHORT A: Participants must not have clinically significant autoimmune disease
  • COHORT A: Participants must be able to take oral medications and comply with the oral regimen Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications. Administration via nasogastric/gastrostomy (NG/G)-tube is acceptable as long as oral solution is used

  • COHORT A: Participants must not have uncontrolled intercurrent illness including, but not limited to:

    • Active central nervous system status 3 (CNS3) or CNS2 (CNS leukemia)

      • Note: Participants with CNS1 or who had prior CNS2 or CNS3 are eligible if this has cleared and have become CNS-1
    • Currently requiring supplemental oxygen (more than 2 liters per minute), mechanical ventilation, vasopressors
  • COHORT A: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen

  • COHORT A: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen

    • Note: Participants of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment
  • COHORT B: Participant must be ≥ 55 years old at the time of registration
  • COHORT B: Participant must have Zubrod/ECOG performance status of 0-2
  • COHORT B: Participants must have a complete medical history and physical exam within 28 days prior to registration
  • COHORT B: GFR ≥ 50 ml/min/1.73 m^2 (within 14 days prior to registration)

  • COHORT B: Direct bilirubin ≤ 2.0 mg/dL (34.2 micromoles/L) (within 14 days prior to registration)

    • Note: Participants with history of Gilbert's disease or elevated bilirubin is related to underlying leukemia must have direct bilirubin ≤ 5 x institutional ULN
  • COHORT B: ALT ≤ 5 x institutional ULN unless abnormal liver tests are related to underlying leukemia (within 14 days prior to registration)
  • COHORT B: Participants must have a calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 14 days prior to registration
  • COHORT B: Participants must have adequate cardiac function. Participants must have cardiac ejection fraction ≥ 50% by MUGA or 2-D echocardiogram within 28 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
  • COHORT B: Participants with a known history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
  • COHORT B: Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated
  • COHORT B: Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated
  • COHORT B: Participants must have a lumbar puncture to determine CNS involvement of ALL within 14 days prior to registration. Intrathecal cytarabine and/or methotrexate administered prior to study registration may count as the first dose of intrathecal therapy required as part of protocol therapy
  • COHORT B: Participants must not have an active uncontrolled infection
  • COHORT B: Participants must not have prolonged QTcf defined as > 450 msec participants on screening EKG prior to registration
  • COHORT B: Participants must not have known clinical signs of bulk central nervous system involvement (CNS3c), such as facial palsy, brain/eye involvement or hypothalamic syndrome
  • COHORT B: Participants must be able to take oral medications and comply with the oral regimen Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications. Administration via NG/G-tube is acceptable as long as oral solution is used
  • COHORT B: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen

  • COHORT B: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen

    • Note: Participants of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment
  • ALL COHORTS: Participants must be offered the opportunity to participate in specimen collection submitted for translational medicine work. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System

  • NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

    • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
    • For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
    • This trial will use a slot reservation system to enroll the feasibility and safety run-in portions of the study for Cohort A and Cohort B. Patients planning to enroll at this portion of the study must first have a slot reserved in advance of the registration. All site staff will use OPEN to create a slot reservation

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Cohort A, Arm 1 (revumenib and blinatumomab)
See Detailed Description.
Arzneimittel: Cyclophosphamid
Gegeben IV
Andere Namen:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamid
  • 2H-1,3,2-Oxazaphosphorin, 2-[Bis(2-chlorethyl)amino]tetrahydro-, 2-Oxid, Monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP-Monohydrat
  • CYCLO-Zelle
  • Cycloblastin
  • Cyclophospham
  • Cyclophosphamid-Monohydrat
  • Cyclophosphamid
  • Cyclophosphan
  • Cyclophosphanum
  • Cyclostin
  • Cytophosphan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmun
  • Syklofosfamid
  • WR-138719
  • Asta B 518
  • B-518
  • B 518
  • B518
  • WR 138719
  • WR138719
Arzneimittel: Mercaptopurin
PO gegeben
Andere Namen:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-thiol
  • 6MP
  • 6 Thiohypoxanthin
  • 6 Thiopurin
  • 6-Mercaptopurin
  • 6-Mercaptopurin-Monohydrat
  • 6-Purinthiol
  • 6-Thiopurin
  • 6-Thioxopurin
  • 6H-Purin-6-thion, 1,7-dihydro- (9CI)
  • 7-Mercapto-1,3,4,6-tetrazainden
  • Alti-Mercaptopurin
  • Azathiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Merkalukim
  • Merkalukin
  • Merkaptina
  • Merkaptopurin
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purin, 6-Mercapto-
  • Purin-6-thiol (8CI)
  • Purin-6-thiol, Monohydrat
  • Purinthiol
  • U-4748
  • WR-2785
Arzneimittel: Dexamethason
Gegeben PO oder IV
Andere Namen:
  • Dekadron
  • Hämady
  • Aacidexam
  • Adexon
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Ohrmuschel
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisummann
  • Dekoort
  • Decadrol
  • Zehner DP
  • Abziehbild
  • Dekameth
  • Decason R.p.
  • Dectanzyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desamethason
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-Sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalokal
  • Dexamecortin
  • Dexameth
  • Dexamethason Intensol
  • Dexamethason
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexon
  • Dinormon
  • Dxevo
  • Fluordelta
  • Fortekortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Lieberin
  • Methylfluorprednisolon
  • Millicorten
  • Mymethason
  • Orgadrone
  • Streudex
  • TaperDex
  • Visumetazone
  • ZoDex
  • LenaDex
Arzneimittel: Vincristin
Gegeben IV
Andere Namen:
  • Videorecorder
  • Leurocristin
  • Vincrystin
  • LCR
Biologisch: Blinatumomab
Gegeben IV
Andere Namen:
  • Blincyto
  • Bispezifischer monoklonaler Anti-CD19 x Anti-CD3-Antikörper
  • Rekombinanter bispezifischer monoklonaler Anti-CD19/Anti-CD3-Antikörper MT103
  • MEDI-538
  • MT-103
  • AMG103
  • MT103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Arzneimittel: Thioguanin
PO gegeben
Andere Namen:
  • 6-TG
  • 2-Amino 6MP
  • 2-Amino-1,7-dihydro-6H-purin-6-thion
  • 2-Amino-6-mercaptopurin
  • 2-Amino-6-purinthiol
  • 2-Aminopurin-6-thiol
  • 2-Aminopurin-6(1H)-thion
  • 2-Aminopurin-6-thiol-Hemihydrat
  • 2-Mercapto-6-aminopurin
  • 6-Amino-2-mercaptopurin
  • 6-Mercapto-2-aminopurin
  • 6-Mercaptoguanin
  • 6H-Purin-6-thion, 2-amino-1,7-dihydro- (9CI)
  • BW5071
  • Lanvis
  • Boulevardzeitung
  • Thioguanin-Hemihydrat
  • Thioguaninhydrat
  • Tioguanin
  • Willkommen U3B
  • WR-1141
  • X27
Arzneimittel: Doxorubicin
Gegeben IV
Andere Namen:
  • Adriablastin
  • Hydroxydaunomycin
  • Hydroxyl-Daunorubicin
  • Hydroxyldaunorubicin
Verfahren: Multigated Acquisition Scan
Unterziehen Sie sich MUGA
Andere Namen:
  • Blutpool-Scan
  • Gleichgewichts-Radionuklid-Angiographie
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid-Ventrikulographie
  • RNVG
  • SYMA-Scannen
  • Synchronisiertes Multigated Acquisition Scanning
  • MUGA-Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid-Ventrikulogramm-Scan
  • Gated Heart Pool-Scan
  • RNV-Scan
Verfahren: Positronen-Emissions-Tomographie
Unterziehe dich einer PET/CT
Andere Namen:
  • Medizinische Bildgebung, Positronen-Emissions-Tomographie
  • HAUSTIER
  • PET-Scan
  • Positronen-Emissions-Tomographie-Scan
  • Positronen-Emissions-Tomographie
  • Pt
  • Positronen-Emissions-Tomographie (Verfahren)
Arzneimittel: Leucovorin-Kalzium
Gegeben PO oder IV
Andere Namen:
  • Wellcovorin
  • Folinsäure
  • Adinepar
  • Calcifolin
  • Calcium (6S)-Folinat
  • Calciumfolinat
  • Calcium Leucovorin
  • Kalfolex
  • Kalinat
  • Cehafolin
  • Citofolin
  • Citrec
  • Citrovorum-Faktor
  • Cromatonbic Folinico
  • Dalisol
  • Desintox
  • Divikal
  • Ecofol
  • Emovis
  • Faktor, Citrovorum
  • Flynoken A
  • Folaren
  • Folaxin
  • FOLI-Zelle
  • Foliben
  • Folidan
  • Folidar
  • Folinac
  • Folinat Calcium
  • Folinsäure-Calciumsalz-Pentahydrat
  • Folinoral
  • Folinvit
  • Foliplus
  • Folix
  • Imo
  • Lederfolat
  • Lederfolin
  • Leucosar
  • Leucovorin
  • Rescufolin
  • Rescuvolin
  • Tonofolin
Verfahren: Thorax-Radiographie
Unterziehe dich einer Röntgenaufnahme des Brustkorbs
Andere Namen:
  • Brust Röntgen
Verfahren: Knochenmarkbiopsie
Unterziehen Sie sich einer Knochenmarkbiopsie und Aspiration
Andere Namen:
  • Biopsie des Knochenmarks
  • Biopsie, Knochenmark
Arzneimittel: Methotrexat
Gegeben IT oder IV
Andere Namen:
  • Abbitrexat
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexat
  • CL14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexat
  • Lumexon
  • Maxtrex
  • Medsatrexat
  • Metex
  • Methoblastin
  • Methotrexat LPF
  • Methotrexat Methylaminopterin
  • Methotrexat
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Text
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Jylamvo
Arzneimittel: Cytarabin
Gegeben IV oder SC
Andere Namen:
  • Β-Cytosinarabinosid
  • 1-β-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-β-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-Arabinofuranosylcytosin
  • 1β-D-Arabinofuranosylcytosin
  • 2(1H)-Pyrimidinon, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinon, 4-Amino-1β-D-arabinofuranosyl-
  • Alexander
  • Ara-C
  • ARA-Zelle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Beta-Cytosin-Arabinosid
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinosid
  • Cytosin-β-arabinosid
  • Cytosin-beta-Arabinosid
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Verfahren: Computertomographie
Unterziehen Sie sich einem CT oder PET/CT
Andere Namen:
  • CT
  • KATZE
  • Computertomographie
  • Computergestützte axiale Tomographie
  • CT-Scan
  • Tomographie
  • Computerisierte Axialtomographie (Verfahren)
  • Computertomographie (CT)-Scan
  • Diagnosekatze Scan
  • Diagnose -Katzen -Scan -Service -Typ
Arzneimittel: Calaspargase Pegol
Gegeben IV
Andere Namen:
  • Asparaginase (Escherichia coli Isoenzym II), Konjugat mit alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethandiyl)
  • Spargel
  • EZN-2285
  • SC-PEG E. Coli L-Asparaginase
  • Succinimidylcarbonat Monomethoxypolyethylenglykol E. coli L-Asparaginase
  • Calaspargase Pegol-mknl
Verfahren: Sammlung von Bioproben
Unterziehen Sie sich einer Liquor- und Blutprobenentnahme
Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung
Arzneimittel: Revumenib
Gegeben PO
Andere Namen:
  • Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613
  • Menin-MLL-Inhibitor SNDX-5613
  • Menin-MLL-Interaktionsinhibitor SNDX-5613
  • SNDX 5613
  • SNDX-5613
  • SNDX5613
Verfahren: Knochenmark Aspiration
Unterziehen Sie sich einer Knochenmarkbiopsie und -punktion
Verfahren: Echokardiographie -Test
Echo unterziehen
Andere Namen:
  • Echokardiographie
  • EG
Aktiver Komparator: Cohort A, Arm 2 (blinatumomab)
See Detailed Description.
Arzneimittel: Cyclophosphamid
Gegeben IV
Andere Namen:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamid
  • 2H-1,3,2-Oxazaphosphorin, 2-[Bis(2-chlorethyl)amino]tetrahydro-, 2-Oxid, Monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP-Monohydrat
  • CYCLO-Zelle
  • Cycloblastin
  • Cyclophospham
  • Cyclophosphamid-Monohydrat
  • Cyclophosphamid
  • Cyclophosphan
  • Cyclophosphanum
  • Cyclostin
  • Cytophosphan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmun
  • Syklofosfamid
  • WR-138719
  • Asta B 518
  • B-518
  • B 518
  • B518
  • WR 138719
  • WR138719
Arzneimittel: Mercaptopurin
PO gegeben
Andere Namen:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-thiol
  • 6MP
  • 6 Thiohypoxanthin
  • 6 Thiopurin
  • 6-Mercaptopurin
  • 6-Mercaptopurin-Monohydrat
  • 6-Purinthiol
  • 6-Thiopurin
  • 6-Thioxopurin
  • 6H-Purin-6-thion, 1,7-dihydro- (9CI)
  • 7-Mercapto-1,3,4,6-tetrazainden
  • Alti-Mercaptopurin
  • Azathiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Merkalukim
  • Merkalukin
  • Merkaptina
  • Merkaptopurin
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purin, 6-Mercapto-
  • Purin-6-thiol (8CI)
  • Purin-6-thiol, Monohydrat
  • Purinthiol
  • U-4748
  • WR-2785
Arzneimittel: Dexamethason
Gegeben PO oder IV
Andere Namen:
  • Dekadron
  • Hämady
  • Aacidexam
  • Adexon
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Ohrmuschel
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisummann
  • Dekoort
  • Decadrol
  • Zehner DP
  • Abziehbild
  • Dekameth
  • Decason R.p.
  • Dectanzyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desamethason
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-Sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalokal
  • Dexamecortin
  • Dexameth
  • Dexamethason Intensol
  • Dexamethason
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexon
  • Dinormon
  • Dxevo
  • Fluordelta
  • Fortekortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Lieberin
  • Methylfluorprednisolon
  • Millicorten
  • Mymethason
  • Orgadrone
  • Streudex
  • TaperDex
  • Visumetazone
  • ZoDex
  • LenaDex
Arzneimittel: Vincristin
Gegeben IV
Andere Namen:
  • Videorecorder
  • Leurocristin
  • Vincrystin
  • LCR
Biologisch: Blinatumomab
Gegeben IV
Andere Namen:
  • Blincyto
  • Bispezifischer monoklonaler Anti-CD19 x Anti-CD3-Antikörper
  • Rekombinanter bispezifischer monoklonaler Anti-CD19/Anti-CD3-Antikörper MT103
  • MEDI-538
  • MT-103
  • AMG103
  • MT103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Arzneimittel: Thioguanin
PO gegeben
Andere Namen:
  • 6-TG
  • 2-Amino 6MP
  • 2-Amino-1,7-dihydro-6H-purin-6-thion
  • 2-Amino-6-mercaptopurin
  • 2-Amino-6-purinthiol
  • 2-Aminopurin-6-thiol
  • 2-Aminopurin-6(1H)-thion
  • 2-Aminopurin-6-thiol-Hemihydrat
  • 2-Mercapto-6-aminopurin
  • 6-Amino-2-mercaptopurin
  • 6-Mercapto-2-aminopurin
  • 6-Mercaptoguanin
  • 6H-Purin-6-thion, 2-amino-1,7-dihydro- (9CI)
  • BW5071
  • Lanvis
  • Boulevardzeitung
  • Thioguanin-Hemihydrat
  • Thioguaninhydrat
  • Tioguanin
  • Willkommen U3B
  • WR-1141
  • X27
Arzneimittel: Doxorubicin
Gegeben IV
Andere Namen:
  • Adriablastin
  • Hydroxydaunomycin
  • Hydroxyl-Daunorubicin
  • Hydroxyldaunorubicin
Verfahren: Multigated Acquisition Scan
Unterziehen Sie sich MUGA
Andere Namen:
  • Blutpool-Scan
  • Gleichgewichts-Radionuklid-Angiographie
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid-Ventrikulographie
  • RNVG
  • SYMA-Scannen
  • Synchronisiertes Multigated Acquisition Scanning
  • MUGA-Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid-Ventrikulogramm-Scan
  • Gated Heart Pool-Scan
  • RNV-Scan
Verfahren: Positronen-Emissions-Tomographie
Unterziehe dich einer PET/CT
Andere Namen:
  • Medizinische Bildgebung, Positronen-Emissions-Tomographie
  • HAUSTIER
  • PET-Scan
  • Positronen-Emissions-Tomographie-Scan
  • Positronen-Emissions-Tomographie
  • Pt
  • Positronen-Emissions-Tomographie (Verfahren)
Arzneimittel: Leucovorin-Kalzium
Gegeben PO oder IV
Andere Namen:
  • Wellcovorin
  • Folinsäure
  • Adinepar
  • Calcifolin
  • Calcium (6S)-Folinat
  • Calciumfolinat
  • Calcium Leucovorin
  • Kalfolex
  • Kalinat
  • Cehafolin
  • Citofolin
  • Citrec
  • Citrovorum-Faktor
  • Cromatonbic Folinico
  • Dalisol
  • Desintox
  • Divikal
  • Ecofol
  • Emovis
  • Faktor, Citrovorum
  • Flynoken A
  • Folaren
  • Folaxin
  • FOLI-Zelle
  • Foliben
  • Folidan
  • Folidar
  • Folinac
  • Folinat Calcium
  • Folinsäure-Calciumsalz-Pentahydrat
  • Folinoral
  • Folinvit
  • Foliplus
  • Folix
  • Imo
  • Lederfolat
  • Lederfolin
  • Leucosar
  • Leucovorin
  • Rescufolin
  • Rescuvolin
  • Tonofolin
Verfahren: Thorax-Radiographie
Unterziehe dich einer Röntgenaufnahme des Brustkorbs
Andere Namen:
  • Brust Röntgen
Verfahren: Knochenmarkbiopsie
Unterziehen Sie sich einer Knochenmarkbiopsie und Aspiration
Andere Namen:
  • Biopsie des Knochenmarks
  • Biopsie, Knochenmark
Arzneimittel: Methotrexat
Gegeben IT oder IV
Andere Namen:
  • Abbitrexat
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexat
  • CL14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexat
  • Lumexon
  • Maxtrex
  • Medsatrexat
  • Metex
  • Methoblastin
  • Methotrexat LPF
  • Methotrexat Methylaminopterin
  • Methotrexat
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Text
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Jylamvo
Arzneimittel: Cytarabin
Gegeben IV oder SC
Andere Namen:
  • Β-Cytosinarabinosid
  • 1-β-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-β-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-Arabinofuranosylcytosin
  • 1β-D-Arabinofuranosylcytosin
  • 2(1H)-Pyrimidinon, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinon, 4-Amino-1β-D-arabinofuranosyl-
  • Alexander
  • Ara-C
  • ARA-Zelle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Beta-Cytosin-Arabinosid
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinosid
  • Cytosin-β-arabinosid
  • Cytosin-beta-Arabinosid
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Verfahren: Computertomographie
Unterziehen Sie sich einem CT oder PET/CT
Andere Namen:
  • CT
  • KATZE
  • Computertomographie
  • Computergestützte axiale Tomographie
  • CT-Scan
  • Tomographie
  • Computerisierte Axialtomographie (Verfahren)
  • Computertomographie (CT)-Scan
  • Diagnosekatze Scan
  • Diagnose -Katzen -Scan -Service -Typ
Arzneimittel: Calaspargase Pegol
Gegeben IV
Andere Namen:
  • Asparaginase (Escherichia coli Isoenzym II), Konjugat mit alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethandiyl)
  • Spargel
  • EZN-2285
  • SC-PEG E. Coli L-Asparaginase
  • Succinimidylcarbonat Monomethoxypolyethylenglykol E. coli L-Asparaginase
  • Calaspargase Pegol-mknl
Verfahren: Sammlung von Bioproben
Unterziehen Sie sich einer Liquor- und Blutprobenentnahme
Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung
Verfahren: Knochenmark Aspiration
Unterziehen Sie sich einer Knochenmarkbiopsie und -punktion
Verfahren: Echokardiographie -Test
Echo unterziehen
Andere Namen:
  • Echokardiographie
  • EG
Experimental: Cohort B (revumenib and blinatumomab)
See Detailed Description.
Arzneimittel: Daunorubicinhydrochlorid
Gegeben IV
Andere Namen:
  • Cerubidin
  • Cloridrato de Daunorubicina
  • Daunoblastin
  • Daunoblastina
  • Daunomycinhydrochlorid
  • Daunomycin, Hydrochlorid
  • Daunorubicin.HCl
  • Daunorubicini hydrochloridum
  • FI-6339
  • Ondena
  • RP-13057
  • Rubidomycinhydrochlorid
  • Rubilem
Arzneimittel: Dexamethason
Gegeben PO oder IV
Andere Namen:
  • Dekadron
  • Hämady
  • Aacidexam
  • Adexon
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Ohrmuschel
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisummann
  • Dekoort
  • Decadrol
  • Zehner DP
  • Abziehbild
  • Dekameth
  • Decason R.p.
  • Dectanzyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desamethason
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-Sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalokal
  • Dexamecortin
  • Dexameth
  • Dexamethason Intensol
  • Dexamethason
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexon
  • Dinormon
  • Dxevo
  • Fluordelta
  • Fortekortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Lieberin
  • Methylfluorprednisolon
  • Millicorten
  • Mymethason
  • Orgadrone
  • Streudex
  • TaperDex
  • Visumetazone
  • ZoDex
  • LenaDex
Arzneimittel: Vincristin
Gegeben IV
Andere Namen:
  • Videorecorder
  • Leurocristin
  • Vincrystin
  • LCR
Biologisch: Blinatumomab
Gegeben IV
Andere Namen:
  • Blincyto
  • Bispezifischer monoklonaler Anti-CD19 x Anti-CD3-Antikörper
  • Rekombinanter bispezifischer monoklonaler Anti-CD19/Anti-CD3-Antikörper MT103
  • MEDI-538
  • MT-103
  • AMG103
  • MT103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Verfahren: Positronen-Emissions-Tomographie
Unterziehe dich einer PET/CT
Andere Namen:
  • Medizinische Bildgebung, Positronen-Emissions-Tomographie
  • HAUSTIER
  • PET-Scan
  • Positronen-Emissions-Tomographie-Scan
  • Positronen-Emissions-Tomographie
  • Pt
  • Positronen-Emissions-Tomographie (Verfahren)
Verfahren: Knochenmarkbiopsie
Unterziehen Sie sich einer Knochenmarkbiopsie und Aspiration
Andere Namen:
  • Biopsie des Knochenmarks
  • Biopsie, Knochenmark
Arzneimittel: Methotrexat
Gegeben IT oder IV
Andere Namen:
  • Abbitrexat
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexat
  • CL14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexat
  • Lumexon
  • Maxtrex
  • Medsatrexat
  • Metex
  • Methoblastin
  • Methotrexat LPF
  • Methotrexat Methylaminopterin
  • Methotrexat
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Text
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Jylamvo
Arzneimittel: Cytarabin
Gegeben IV oder SC
Andere Namen:
  • Β-Cytosinarabinosid
  • 1-β-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-β-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-Arabinofuranosylcytosin
  • 1β-D-Arabinofuranosylcytosin
  • 2(1H)-Pyrimidinon, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinon, 4-Amino-1β-D-arabinofuranosyl-
  • Alexander
  • Ara-C
  • ARA-Zelle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Beta-Cytosin-Arabinosid
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinosid
  • Cytosin-β-arabinosid
  • Cytosin-beta-Arabinosid
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Verfahren: Computertomographie
Unterziehen Sie sich einem CT oder PET/CT
Andere Namen:
  • CT
  • KATZE
  • Computertomographie
  • Computergestützte axiale Tomographie
  • CT-Scan
  • Tomographie
  • Computerisierte Axialtomographie (Verfahren)
  • Computertomographie (CT)-Scan
  • Diagnosekatze Scan
  • Diagnose -Katzen -Scan -Service -Typ
Verfahren: Sammlung von Bioproben
Unterziehen Sie sich einer Liquor- und Blutprobenentnahme
Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung
Arzneimittel: Revumenib
Gegeben PO
Andere Namen:
  • Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613
  • Menin-MLL-Inhibitor SNDX-5613
  • Menin-MLL-Interaktionsinhibitor SNDX-5613
  • SNDX 5613
  • SNDX-5613
  • SNDX5613
Verfahren: Knochenmark Aspiration
Unterziehen Sie sich einer Knochenmarkbiopsie und -punktion

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Dose limiting toxicities (Safety run-in: Cohort A)
Zeitfenster: During cycle 1 (cycle 1 length = 28 days)
Will be evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0. Will evaluate the proportion of participants with dose limiting toxicities and exact confidence intervals.
During cycle 1 (cycle 1 length = 28 days)
Measurable residual disease (MRD) negativity rate (Cohort A)
Zeitfenster: Up to 35 days after start of therapy
Difference in proportion of participants who achieve clonoSEQ MRD status between the two arms will be compared using a two-sample proportion test.
Up to 35 days after start of therapy
MRD-event-free survival (EFS) (Cohort A)
Zeitfenster: From date of randomization and up to 10 years
Will be compared using unstratified log-rank test.
From date of randomization and up to 10 years
Incidence of toxicities of interest (TOI) (Cohort B)
Zeitfenster: Up to 30 days after last dose of study treatment
TOI rates will be reported with exact 90% confidence intervals.
Up to 30 days after last dose of study treatment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of adverse events
Zeitfenster: Up to 30 days after last dose of study treatment
Frequency and severity within each arm and across cycles of therapy will be assessed using NCI CTCAE v 6.0.
Up to 30 days after last dose of study treatment
MRD negative complete remission (CR) rate (Cohort A)
Zeitfenster: Up to 70 days after start of therapy
Will be evaluated in participants with positive MRD before randomization.
Up to 70 days after start of therapy
EFS (Cohort A)
Zeitfenster: At 6 months
Will be estimated using the Kaplan-Meier method. Will be evaluated in participants with negative MRD before randomization.
At 6 months
MRD-EFS (Cohort A)
Zeitfenster: At 6 months
Will be estimated using the Kaplan-Meier method. Will be evaluated in participants with negative MRD before randomization.
At 6 months
Composite morphological CR rate (Cohort B)
Zeitfenster: Up to 35 days after start of therapy
Will be defined as CR/CR with incomplete count recovery (CRi).
Up to 35 days after start of therapy
Proportion of participants MRD negative (Cohorts A and B)
Zeitfenster: Up to 35 days after start of therapy
Will be evaluated using multi-color flow cytometry.
Up to 35 days after start of therapy
Rate of lineage switch and/or CD19-negative relapse (within each arm and cohort cohort)
Zeitfenster: Up to 10 years
Up to 10 years
Rate of allogeneic hematopoietic stem cell transplantation utilization (within each arm and cohort cohort)
Zeitfenster: Up to 10 years
Up to 10 years
EFS (within each arm and cohort cohort)
Zeitfenster: From the date of trial registration/randomization until the first of death from any cause, relapse from remission, secondary malignancy, or completion of protocol therapy, assessed up to 10 years
Will be reported within each arm and cohort and by age. Will be estimated using the Kaplan-Meier method.
From the date of trial registration/randomization until the first of death from any cause, relapse from remission, secondary malignancy, or completion of protocol therapy, assessed up to 10 years
MRD-EFS (within each arm and cohort cohort)
Zeitfenster: From the date of trial registration/randomization until the first of death from any cause, relapse from remission, secondary malignancy, or completion of protocol therapy, assessed up to 10 years
Will be reported within each arm and cohort and by age. Will be estimated using the Kaplan-Meier method.
From the date of trial registration/randomization until the first of death from any cause, relapse from remission, secondary malignancy, or completion of protocol therapy, assessed up to 10 years
Relapse-free survival (within each arm and cohort cohort)
Zeitfenster: From date of trial registration until relapse from CR/CRi or death from any cause, assessed up to 10 years
Will be reported within each arm and cohort and by age. Will be estimated using the Kaplan-Meier method.
From date of trial registration until relapse from CR/CRi or death from any cause, assessed up to 10 years
Progression-free survival (PFS) (within each arm and cohort cohort)
Zeitfenster: From the date of trial registration/randomization until the first of progression, death from any cause, relapse from morphologic remission, secondary malignancy, or completion of protocol therapy, assessed up to 10 years
Will be reported within each arm and cohort and by age. Will be estimated using the Kaplan-Meier method.
From the date of trial registration/randomization until the first of progression, death from any cause, relapse from morphologic remission, secondary malignancy, or completion of protocol therapy, assessed up to 10 years
MRD-PFS (within each arm and cohort cohort)
Zeitfenster: From the date of trial registration/randomization until the first of progression, death from any cause, relapse from morphologic remission, secondary malignancy, or completion of protocol therapy, assessed up to 10 years
Will be reported within each arm and cohort and by age. Will be estimated using the Kaplan-Meier method.
From the date of trial registration/randomization until the first of progression, death from any cause, relapse from morphologic remission, secondary malignancy, or completion of protocol therapy, assessed up to 10 years
Time to MRD relapse (within each arm and cohort cohort)
Zeitfenster: Up to 10 years
Will be assessed using flow cytometry and/or clonoSEQ.
Up to 10 years
Overall survival (within each arm and cohort cohort)
Zeitfenster: From day of trial registration until death from any cause, assessed up to 10 years
Will be estimated using the Kaplan-Meier method.
From day of trial registration until death from any cause, assessed up to 10 years
Remission rate
Zeitfenster: Up to 10 years
Will be defined as CR/CRi/CR with partial hematological recovery) with and without MRD by flow. Will be estimated with 95% binomial confidence intervals.
Up to 10 years

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Frequency of MEN1 mutations
Zeitfenster: Up to 10 years after start of therapy
Will be evaluated by quantitative polymerase chain reaction (PCR) and/or high sensitivity next generation sequencing.
Up to 10 years after start of therapy
Rate of KMT2A fusion reverse transcriptase (RT)-PCR MRD negativity within treatment arms (Cohort A)
Zeitfenster: After the first and second cycle of blinatumomab (cycle length = 28 days)
After the first and second cycle of blinatumomab (cycle length = 28 days)
KMT2A fusion RT-PCR MRD negativity (Cohort B)
Zeitfenster: Up to 90 days after start of therapy
Up to 90 days after start of therapy
Rate of IG/TR V(D)J MRD negative remission
Zeitfenster: Up to 35 days after start of therapy
Up to 35 days after start of therapy
Changes in gene expression between diagnosis (in Cohort B and as available in Cohort A) and relapse samples
Zeitfenster: Up to 10 years
Up to 10 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

SWOG Cancer Research Network

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Ibrahim Aldoss, SWOG Cancer Research Network

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

14. Oktober 2026

Primärer Abschluss (Geschätzt)

16. April 2031

Studienabschluss (Geschätzt)

16. April 2032

Studienanmeldedaten

Zuerst eingereicht

22. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juni 2026

Zuerst gepostet (Tatsächlich)

9. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • S2507 (Andere Kennung: CTEP)
  • U10CA180888 (US NIH Stipendium/Vertrag)
  • NCI-2026-03381 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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